epoetin alfa (Epogen/Procrit)
epoetin alfa is an FDA-licensed reference biologic from Amgen Inc., with 1 approved follow-on biologic. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
1
Biosimilars
0
Interchangeables
0
Listed patents
—
Reference approved
Reference product
Epogen/Procrit epoetin alfa
Amgen Inc.
- Approved
- Not listed
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for epoetin alfa, in chronological order.
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
28 yr 10 mo ago
Biosimilars & interchangeables for epoetin alfa
1 FDA-licensed follow-on biologic referencing epoetin alfa.
| Product | Proper name | Applicant | Type | BLA | Approved |
|---|---|---|---|---|---|
| Retacrit | epoetin alfa-epbx | Hospira Inc., a Pfizer Company | Biosimilar 351(k) | 125545 | May 15, 2018 |
Frequently asked questions
What biosimilars are approved for epoetin alfa (Epogen/Procrit)?
The FDA Purple Book lists 1 approved follow-on biologic referencing epoetin alfa: Retacrit. Of these, 0 are interchangeable biosimilars and 1 is a 351(k) biosimilar.
Who makes epoetin alfa biosimilars?
Companies with FDA-approved follow-on biologics referencing epoetin alfa include Hospira Inc., a Pfizer Company.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.